Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00124449

Purpose

The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: Abatacept Drug: placebo	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Proportion of subjects wih a diagnosis of Rheumatoid Arthritis by ARA criteria [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with a diagnosis of RA by 1987 ARA criteria [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
the proportion of subjects with persistent symptomatic clinical synovitis [ Time Frame: at 6, 12, and 24 months ] [ Designated as safety issue: No ]
the mean DAS 28 (crp) score [ Time Frame: at 6, 12, and 24 months ] [ Designated as safety issue: No ]

Enrollment:	57
Study Start Date:	February 2005
Study Completion Date:	April 2008
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Abatacept solution, intravenous injection, monthly, 169 days weight based: <60 kg = 500 mg 60 to 100 kg = 750 mg >100 kg = 1 g
2: Placebo Comparator	Drug: placebo solution, intravenous injection, 0 mg, monthly, 169 days

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of undifferentiated arthritis
Clinical synovitis of two or more joints
At least one but not more than three of the criteria for diagnosis of RA (1987).
No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics.
Duration of disease must be 18 months or less.
Positive for antibodies against cyclic citrullinated peptides.

Exclusion Criteria:

Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy.
Active vasculitis of a major organ system.
Severe or recurrent bacterial infection.
History of cancer in the last five years except certain skin cancers.
Herpes zoster that resolved less than 2 months prior to enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124449

Show 48 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-046
Study First Received:	June 30, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00124449
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Abatacept
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs

Antirheumatic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009